Solid oral dosage forms of amiodarone produced by 3D printing within a hospital pharmacy

S. Cailleaux1, S. Roulon3, V. Delannoy1, F. Maillard1, J. Alié3 et I. Soulairol1,2
1 Pharmacie, Centre Hospitalier Universitaire de Nîmes, Nîmes, France
2 ICGM, Université de Montpellier, CNRS, ENSCM, Montpellier, France
1 Sanofi R&D, Service de caractérisation de l’état solide et impression 3D, Montpellier, France

Context and Objective
Today, the use of 3D printing technique by Fused Deposition Modeling to produce oral dosage forms has been demonstrated successful in research laboratories but not in a hospital pharmacy (HP). This work aims to assess the feasibility of producing oral 3D prints (3Dp) of amiodarone from a filament supplied by a pharmaceutical laboratory within a HP.

Methods
Using a 3D printer (Prusa® MK3S), 3 doses (25, 140 and 200 mg) of 3Dp amiodarone were produced, 3 times by 3 operators, who received one hour’s training on using the printer. Batches of 25 units were made from the 20% (w/w) amiodarone filament supplied. The 9 batches produced were then subjected to uniformity of mass (UM) (2.9.5) and uniformity of content (UC) (2.9.6) of single-dose preparations according to the European Pharmacopoeia. The time required to manufacture these batches was measured. Production and control stages were carried out in a production and control unit for pharmaceutical preparations in a pharmacy of a university hospital center.

Results
The UM results for the 9 batches produced are all compliant with average masses between 125.2 and 131.4 mg for the 3Dp at 25 mg, 695.6 and 731.3 mg for the 3Dp at 140 mg and 1029.3 and 1031.0 for the 3Dp at 200 mg. The coefficients of variation (CV) of these tests are less than 4%. All the results of the UTs are also in conformity with average contents between 24.3 and 26.0 mg, 138.7 and 145.4 mg and 200.7 and 211.2 mg. The CVs of these tests are less than 6%. The average handling time (pre-printing and post-printing) is the 20 to 30 minutes. As for the printing time for the 25, 140 and 200 mg batches, they were 21, 110 and 156 minutes, respectively.

Discussion / Conclusion
This study made possible to test the use of this 3D printing technology within an HP in real conditions. The results of the quality controls carried out comply with the requirements of the Pharm. Eur. It can be noted that the training time of the operators was extremely short compared to the time required for the qualification of an operator to produce capsules. The difficulties encountered when handling the printer are linked to the use of a printer not designed for pharmaceutical needs. This last point highlights the need for printers that meet the requirements of Good Preparation or Manufacturing Practices. It will also necessary a fine control of the active content in the filament produced by the industry in order to simplify the quality control performed at the HP. It will remain to define the regulatory status of these printed dosage forms within our HP and to assess their use in the care service.

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